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The Delhi High Court has directed the Government of India to report the outcome of consultations and deliberations with the stakeholders related to the five-year old draft notification for inclusion of rules to regulate online sale of drugs in six weeks, and inform the Court the final stand by the government on the matter.
The High Court also clarified that the pendency of the present matters will not come in the way of the Union of India in taking action against the persons who are violating the interim order issued on December 12, 2018, which is in favour of the chemists and druggists organisations which complain that the current activities of e-pharmacies are against the existing drug regulations. The drug regulator has informed the Court that it is thinking of holding fresh stakeholder consultations related to the matter.
In an order issued by a division bench of Chief Justice Satish Chandra Sharma and Justice Subramonium Prasad, took a status report filed by the Union of India on May 19, 2023, into consideration and said, “The Union of India is granted six weeks’ time to inform the outcome of the consultation and deliberations and also to inform the final stand taken by the Union of India in the matter”. The matter has now been listed for hearing on August 28, 2023.
“It is made clear that the pendency of the present matters will not come in the way of the Union of India in taking action against the persons who are violating the interim order dated December 12, 2018,” it added.
The order comes in a petition filed by Dr Zaheer Ahmed, Delhi-based South Chemists and Distributors Association (SCDA) and others against the Central Government not taking action on the e-pharmacies, among other requests.
In a status note submitted by the Central Drugs Standard Control Organisation (CDSCO), to the Delhi High Court on May 22, 2023 based on an earlier order, said that it has received various representations, views, suggestions, objections from different quarters and stakeholders including non government organisations, civil societies, trade unions, chemists and druggists associations etc on the draft notification issued on August 28, 2018, laying regulations for online pharmacy sales.
The majority of the representations from various stakeholders had opposed the said draft rules of online sale of drugs and the CDSCO has not yet finalised the draft notification and the same is pending for consultations and deliberations. The CDSCO informed the Court that it is contemplating to hold fresh stakeholder consultations with various associations and affected parties in this regard.
It has also informed the Court that the regulator, following the order from the Delhi High Court on December 12, 2018 - which injuncted the e-pharmacies from online sale of medicines without licence and directing the regulator to ensure that the same is prohibited forthwith until further orders - it has communicated to the State and Union Territory drug regulators to implement the direction through letters on May and November, 2019 and in February 3, 2023.
The SCDA in a press release following the favourable order issued on May 22, said, “The Delhi High Court’s decision that action be taken against such illegal entities is a commendable step in ensuring the welfare and protection of the public”. Even after nearly five years from the draft notification, no conclusive stand was taken by the government and the status report submitted by the Government to the High Court this month was also inconclusive on its stand on the operation of e-pharmacies, it added.
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